The present disclosure relates to a connector assembly and more particularly to a flexible connector assembly for an implantable wiring harness. However, it is to be appreciated that the present invention is also amenable to other like environments and applications.
The need for implantable mechanical assist or replacement organs and devices is growing at a fast pace that challenges the ability of the medical industry to develop, test, and commercialize suitable products. While innovative advances in materials, electronics, and technology propel this industry forward, the reliance on conventional approaches to the implantable wiring harnesses that connect these many devices together presents serious obstacles to reliability and implantability.
Implanted wiring harnesses are subjected to a spectrum of forces and environmental stresses that must be withstood throughout the lifetime of the device.
Moreover, as the sophistication and complexity of implanted medical devices increases, there is a corresponding increase in the number of separate power and control channels required in the wiring harness. These wiring harnesses must provide a safe and reliable conduit for electrical power, control signals, and feedback signals to and from power sources, control modules, sensors, and the necessary medical devices. In addition, they must be biocompatible, extremely reliable, easy to install and to replace, and they must be of small enough volume and flexible so as to not detract from patient comfort.
Conventional implantable wiring harness technology relies upon plastic-insulated metallic conductors cabled within a medical grade plastic jacket for the primary conduit. Interconnects are either hardwired at sealed devices (fixed and non-removable) or rely upon conventional connector approaches. These approaches have been adapted from other industries—essentially round rigid bodies with cylindrical coplanar pin and socket inserts packaged in bulky sealed enclosures.
Until recently, very few electrical devices were designed for long term implantation inside the human body. The classic example of implanted wiring is the pacemaker lead. This was once a very troublesome component, although the field has now progressed to a very high degree of reliability. While highly flexed, this application has some advantages. Generally, one lead wire has been involved, with current return through the body to the case of the pulse generator. Most advantageously, the current levels are extremely low, and exotic alloys can be used to construct the lead. These can be very strong and corrosion resistant, but of relatively high resistance. This resistance is insignificant to a pacemaker pulse, but is not as desired to a significant current carrying lead, such as occurs in implanted blood pumps.
Accordingly, the present invention provides a new and improved connector assembly for implanted medical devices which overcomes difficulties with the prior art while providing better and more advantageous overall results.